Home GUDID B3960501020 ESI
Primary DI B3960501020
Brand ESI
Company FTT MEDICAL, INC.
Model 05-0102
Device description "ESI STRAIGHT TRANSILLUMINATOR, 1/4"" DIAMETER, ACMI FITTING."
Published 2016-09-16
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name HJM Transilluminator, Ac-Powered
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HJM Transilluminator, Ac-Powered Ophthalmic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B3960501020 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Skin transilluminator, line-powered A hand-held, mains electricity (AC-powered) device with a built-in light source, usually together with a lens, intended to be used to illuminate the skin and soft tissues, rendering them translucent for examination. It is typically used to examine subcutaneous and scrotal tissue/contents for lesions, and veins (e.g., on the scalp of an infant) for anatomical abnormalities. It can use varying forms of light depending upon the specific application. This device may also be known as a diaphanoscope, a phaneroscope or a light scanner.
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 002212793 Device count 1 Premarket exempt true Lot or batch true Manufacturing date on label true Sterilization required before use true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 04053755202973 FINOFF TRANSILLUMINATOR Heine Optotechnik GmbH & Co. KG HJM 2025-07-17 00810123483167 Vortex Surgical Inc. Vortex Surgical, Inc. HJM 2025-04-18 00810123483150 Vortex Surgical Inc. Vortex Surgical, Inc. HJM 2025-04-18 00632307002359 25GA Midfield Endoillumination Probe Peregrine Surgical, Llc HJM 2024-09-24 00632307002366 27GA Midfield Endoillumination Probe Peregrine Surgical, Llc HJM 2024-09-24 00632307002373 23GA Midfield Endoillumination Probe Peregrine Surgical, Llc HJM 2024-09-24 10632307002356 25GA Midfield Endoillumination Probe Peregrine Surgical, Llc HJM 2024-09-24 10632307002363 27GA Midfield Endoillumination Probe Peregrine Surgical, Llc HJM 2024-09-24 10632307002370 23GA Midfield Endoillumination Probe Peregrine Surgical, Llc HJM 2024-09-24 04053755119943 OPHTHALMIC EXAMINATION LAMP Heine Optotechnik GmbH & Co. KG HJM 2022-12-21 04053755120109 OPHTHALMIC EXAMINATION LAMP Heine Optotechnik GmbH & Co. KG HJM 2022-12-21 04053755200429 FINOFF TRANSILLUMINATOR Heine Optotechnik GmbH & Co. KG HJM 2022-12-21 04053755199679 WALL TRANSFORMER EN 200 Heine Optotechnik GmbH & Co. KG HJM 2022-12-12 04053755199686 WALL TRANSFORMER EN 200-1 Heine Optotechnik GmbH & Co. KG HJM 2022-12-12 10812594013079 NeoGlo® Disposable Neotech Products LLC HJM 2021-05-20 10812594013086 NeoGlo® Disposable Neotech Products LLC HJM 2021-05-20 00812594013072 NeoGlo Disposable NEOTECH PRODUCTS, INC. HJM 2021-05-20 00812594013089 NeoGlo Disposable NEOTECH PRODUCTS, INC. HJM 2021-05-20 10841305112138 Synergetics SYNERGETICS USA, INC. HJM 2020-05-31 20841305112142 Synergetics SYNERGETICS USA, INC. HJM 2020-05-31 07290109140766 Acculite™ EndoOcular® LUMENIS INC. HJM 2016-09-25 17290109140763 Acculite™ EndoOcular® LUMENIS INC. HJM 2016-09-25 B396050080VT0 ESI FTT MEDICAL, INC. HJM 2016-09-16 B396050100VT0 ESI FTT MEDICAL, INC. HJM 2016-09-16 B3960501120 ESI FTT MEDICAL, INC. HJM 2016-09-16 B396MSK1116050 ESI FTT MEDICAL, INC. HJM 2016-09-16 07290109140759 Acculite™ EndoOcular® LUMENIS INC. HJM 2016-09-12 17290109140756 Acculite™ EndoOcular® LUMENIS INC. HJM 2016-09-12 05055272707794 Finhoff Transilluminator 2.8v KEELER LIMITED HJM 2016-08-16 05055272715140 Transilluminator 3.5v in carton KEELER LIMITED HJM 2016-08-16